Scaling CAR-T Operations: The 7 Handoffs That Require End-to-End Traceability
Personalized cell therapies don’t fail at a single point. They strain at the transitions. Across the CAR-T journey, patient material moves through multiple teams, locations, and systems – each governed by strict FDA regulations, GMP requirements, and SOPs. What has been observed over years of supporting cell therapy organizations is that handoffs, not core science, are where complexity quietly accumulates. Each transition introduces a moment where visibility can narrow, documentation can fragment, and coordination becomes harder than expected. Understanding these handoffs and what they require to remain compliant is increasingly important for CMOs, CDMOs, and biobanks scaling advanced therapy programs. …


